GALAXY G3 GLM910040Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10886704080251), received between Jan 4, 2019 and Apr 17, 2026 — classified as 3 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (23 reports).

1 other recall cover devices cleared under the same FDA submission (K171862); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Separation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) WAS IMPEDED IN THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT BE PUSHED INTO THE MICROCATHETER. IT WAS ALSO REPORTED THAT ¿[THE] DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER PREMATURELY.¿ THE PHYSICIAN RETRACED THE COIL AND REPLACED IT WITH A SECOND 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) AND A THIRD 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1502508S) IN SUCCESSION, THE SECOND AND THE THIRD COILS WERE ALSO IMPEDED IN THE HUB OF THE MICROCATHETER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE SECOND AND THE THIRD COIL AND REPLACED IT WITH A FOURTH COIL FROM ANOTHER MANUFACTURER TO FILL THE ANEURYSM AND DETACHED THIS FOURTH COIL. THE PHYSICIAN THEN PROCEEDED TO DELIVER THE FIFTH COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 2102522S) AND OBSERVED THE DELIVERY WIRE OF THIS FIFTH COIL IN THE DISTAL END OF THE ASSOCIATED MICROCATHETER UNDER IMAGING (NOT YET IN THE BLOOD VESSEL) BUT THE PHYSICIAN COULD NOT OBSERVE THE FIFTH COIL. THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918614 ↗
• MalfunctionApr 17, 2026Material Separation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) WAS IMPEDED IN THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT BE PUSHED INTO THE MICROCATHETER. IT WAS ALSO REPORTED THAT ¿[THE] DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER PREMATURELY.¿ THE PHYSICIAN RETRACED THE COIL AND REPLACED IT WITH A SECOND 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) AND A THIRD 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1502508S) IN SUCCESSION, THE SECOND AND THE THIRD COILS WERE ALSO IMPEDED IN THE HUB OF THE MICROCATHETER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE SECOND AND THE THIRD COIL AND REPLACED IT WITH A FOURTH COIL FROM ANOTHER MANUFACTURER TO FILL THE ANEURYSM AND DETACHED THIS FOURTH COIL. THE PHYSICIAN THEN PROCEEDED TO DELIVER THE FIFTH COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 2102522S) AND OBSERVED THE DELIVERY WIRE OF THIS FIFTH COIL IN THE DISTAL END OF THE ASSOCIATED MICROCATHETER UNDER IMAGING (NOT YET IN THE BLOOD VESSEL) BUT THE PHYSICIAN COULD NOT OBSERVE THE FIFTH COIL. THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918613 ↗
• MalfunctionApr 17, 2026Material Separation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) WAS IMPEDED IN THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT BE PUSHED INTO THE MICROCATHETER. IT WAS ALSO REPORTED THAT ¿[THE] DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER PREMATURELY.¿ THE PHYSICIAN RETRACED THE COIL AND REPLACED IT WITH A SECOND 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) AND A THIRD 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1502508S) IN SUCCESSION, THE SECOND AND THE THIRD COILS WERE ALSO IMPEDED IN THE HUB OF THE MICROCATHETER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE SECOND AND THE THIRD COIL AND REPLACED IT WITH A FOURTH COIL FROM ANOTHER MANUFACTURER TO FILL THE ANEURYSM AND DETACHED THIS FOURTH COIL. THE PHYSICIAN THEN PROCEEDED TO DELIVER THE FIFTH COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 2102522S) AND OBSERVED THE DELIVERY WIRE OF THIS FIFTH COIL IN THE DISTAL END OF THE ASSOCIATED MICROCATHETER UNDER IMAGING (NOT YET IN THE BLOOD VESSEL) BUT THE PHYSICIAN COULD NOT OBSERVE THE FIFTH COIL. THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918612 ↗
• MalfunctionFeb 3, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM VIA FEMORAL ACCESS. FEMORAL ARTERY PUNCTURE WAS DONE TO INSERT 8F OPTIMO FLEX GUIDING CATHETER (TOKAI MEDICAL) TO THE INTERNAL CAROTID ARTERY (ICA), THEN DIRECT ACCESS VIA A GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL) WAS ADVANCED ALONG THE CATHETER TO THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). AN SL-10® MICROCATHETER (STRYKER) WAS ADVANCED TO THE A2 SEGMENT AND AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC) WAS INSERTED INTO THE ANEURYSM VIA THE JAILING TECHNIQUE. THE FIRST COIL, A 3.00MM X 6.00CM GALAXY G3 MINI (GLM930060 / LOT# UNKNOWN) WAS PLACED VIA THE ECHELON 14 MICROCATHETER; IT WAS REPORTED THAT THIS COIL PROTRUDED INTO THE PARENT VESSEL, SO A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS DEPLOYED DURING WINDING VIA THE SL-10® MICROCATHETER. THE FIRST COIL WAS DETACHED. THE SECOND COIL, A 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 30937885) WAS INSERTED INTO THE ECHELON 14 MICROCATHETER, BUT STRONG RESISTANCE WAS FELT INSIDE THE INTRODUCER SHEATH AND IT COULD NOT BE ADVANCED; THE COIL WAS RETRIEVED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637137 ↗
• MalfunctionFeb 3, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM VIA FEMORAL ACCESS. FEMORAL ARTERY PUNCTURE WAS DONE TO INSERT 8F OPTIMO FLEX GUIDING CATHETER (TOKAI MEDICAL) TO THE INTERNAL CAROTID ARTERY (ICA), THEN DIRECT ACCESS VIA A GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL) WAS ADVANCED ALONG THE CATHETER TO THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). AN SL-10® MICROCATHETER (STRYKER) WAS ADVANCED TO THE A2 SEGMENT AND AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC) WAS INSERTED INTO THE ANEURYSM VIA THE JAILING TECHNIQUE. THE FIRST COIL, A 3.00MM X 6.00CM GALAXY G3 MINI ((B)(4) / LOT# UNKNOWN) WAS PLACED VIA THE ECHELON 14 MICROCATHETER; IT WAS REPORTED THAT THIS COIL PROTRUDED INTO THE PARENT VESSEL, SO A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS DEPLOYED DURING WINDING VIA THE SL-10® MICROCATHETER. THE FIRST COIL WAS DETACHED. THE SECOND COIL, A 1.00MM X 4.00CM GALAXY G3 MINI ((B)(4) / 30937885) WAS INSERTED INTO THE ECHELON 14 MICROCATHETER, BUT STRONG RESISTANCE WAS FELT INSIDE THE INTRODUCER SHEATH AND IT COULD NOT BE ADVANCED; THE COIL WAS RETRIEVED. THE THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637130 ↗
• MalfunctionFeb 3, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM VIA FEMORAL ACCESS. FEMORAL ARTERY PUNCTURE WAS DONE TO INSERT 8F OPTIMO FLEX GUIDING CATHETER (TOKAI MEDICAL) TO THE INTERNAL CAROTID ARTERY (ICA), THEN DIRECT ACCESS VIA A GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL) WAS ADVANCED ALONG THE CATHETER TO THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). AN SL-10® MICROCATHETER (STRYKER) WAS ADVANCED TO THE A2 SEGMENT AND AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC) WAS INSERTED INTO THE ANEURYSM VIA THE JAILING TECHNIQUE. THE FIRST COIL, A 3.00MM X 6.00CM GALAXY G3 MINI (GLM930060 / LOT# UNKNOWN) WAS PLACED VIA THE ECHELON 14 MICROCATHETER; IT WAS REPORTED THAT THIS COIL PROTRUDED INTO THE PARENT VESSEL, SO A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS DEPLOYED DURING WINDING VIA THE SL-10® MICROCATHETER. THE FIRST COIL WAS DETACHED. THE SECOND COIL, A 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 30937885) WAS INSERTED INTO THE ECHELON 14 MICROCATHETER, BUT STRONG RESISTANCE WAS FELT INSIDE THE INTRODUCER SHEATH AND IT COULD NOT BE ADVANCED; THE COIL WAS RETRIEVED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637107 ↗
• MalfunctionJan 18, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 4CM (GLM910040/ 30541401) COIL WAS IMPEDED IN THE DISTAL END OF THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN WITHDREW THE COIL AND SWITCHED TO A NEW ONE, A GALAXY G3 MINI 1MM X 4CM (GLM910040/30727819), BUT THE SAME ISSUE OCCURRED. THE DOCTOR RETRACTED THE COIL AND CHANGED TO A THIRD COIL WITH SLIGHTLY LARGER SIZE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535422 ↗
• MalfunctionJan 18, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 4CM (GLM910040/ 30541401) COIL WAS IMPEDED IN THE DISTAL END OF THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN WITHDREW THE COIL AND SWITCHED TO A NEW ONE, A GALAXY G3 MINI 1MM X 4CM (GLM910040/30727819), BUT THE SAME ISSUE OCCURRED. THE DOCTOR RETRACTED THE COIL AND CHANGED TO A THIRD COIL WITH SLIGHTLY LARGER SIZE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND KINKED AND UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535421 ↗
• MalfunctionJun 27, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE GALAXY G3 MINI 1MM X 4CM COIL (GLM910040/LOT UNKNOWN) WAS STUCK IN THE INTRODUCER AND COULD NOT ADVANCE. A CONTINUOUS FLUSH WAS NOT DONE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209306 ↗
• MalfunctionJun 26, 2023Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A GALAXY G3 MINI 1MMX4MM (GLM910040/ 30727819) AFTER INSERTING IT INTO THE ECHELON MICROCATHETER, THERE WAS RESISTANCE, AND INSERTION WAS NOT POSSIBLE. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED. CONTINUOUS FLUSH WAS UNKNOWN. ON 07-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED. CATHETER DAMAGE AND OBSTRUCTION WERE NOTED AS UNKNOWN. THE LOCATION WHERE THE RESISTANCE WAS FELT COULD NOT BE OBTAINED. ON 19-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED, STATING THAT NO DEVICE DAMAGE WAS FOUND PRIOR TO USE. AFTER THE COIL WAS INSERTED INTO THE MICROCATHETER AND RESISTANCE WAS FELT, THE CATHETER WAS PULLED, AND A KINK WAS FOUND ON THE SHAFT. IT WAS REPORTED THAT ¿THE CONTRAST AGENT MIGHT OBSTRUCT THE MICROCATHETER, BUT THE COMPETITOR¿S COILS (AXIU, AVENIR) COULD BE INSERTED WITHOUT ANY PROBLEMS.¿. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198158 ↗
• MalfunctionMar 6, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE PHYSICIAN, DURING A COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM FOR THE RIGHT ANGIOMYOLIPOMAS (AML), A GUIDEWIRE (MEISTER S14) AND A MARVEL NON-TAPER 1.9FR/1.9FR MICROCATHETER (MC) WAS USED. A GALAXY G3 MINI COIL (1X3) WAS USED AS THE FIRST COIL WITHOUT ANY ISSUES. THEN, RESISTANCE WAS FELT WITH THE SECOND COIL, A GALAXY G3 MINI 1MM X 4CM (GLM910040, 30494381) WAS INSERTED INTO THE MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. SEVEN COILS (1.5X3) (2X6) (1X4) (1.5X2) (2X3) AND TWO IED COILS WERE USED. NO RESISTANCE OCCURRED WHEN OTHER COILS. THE PROCEDURE WAS COMPLETED SMOOTHLY. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THERE WAS NO DAMAGE DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE DEVICE WAS NOT NOTED TO BEING DAMAGED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL HAS SOME KINKED CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486959 ↗
• MalfunctionDec 16, 2022Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE VERTEBRAL ARTERY, ONE G3 COIL AND ON3 G3 XSFT COIL WERE DETACHED. AFTER THAT, THE FIRST COMPLAINT COIL, A GALAXY G3 MINI 1.00MM X 4.00CM (GLM910040 / 30722166) WAS USED, BUT THERE WAS INTENSIVE RESISTANCE FELT ¿AS IF THE COMPLAINT COIL GOT STUCK ON THE HUB¿ OF THE CONCOMITANT PHENOM¿ 17 MICROCATHETER (MEDTRONIC). THE DELIVERY WIRE WAS RETRACTED BUT IT GOT KINKED AT THE COIL DETACHMENT ZONE. IT WAS REPORTED THAT IT IS NOT KNOWN WHEN THE KINK OCCURRED, BUT ¿THERE WAS REMARKABLE RESISTANCE FELT WHEN THE DELIVERY WIRE WAS INSERTED INTO THE MICROCATHETER.¿. THERE WAS NO STOCK OF THE GALAXY G3 MINI 1.00MM X 4.00CM AVAILABLE AT THE FACILITY, AS A RESULT, A GALAXY G3 MINI 1.50MM X 4.00CM (GLM915040 / 30541404), THE SECOND COMPLAINT COIL WAS USED, BUT IT WAS UNABLE TO ADVANCE AT THE HUB OF THE CONCOMITANT MICROCATHETER. THIS COIL WAS REPLACED WITH A GALAXY G3 MINI 1.00MM X 3.00CM (GLM910030) AND IT WAS DELIVERED TO THE TARGET LESION AND IMPLANTED WITHOUT ANY PROBLEMS. TWO ADDITIONAL COILS, ANOTHER GALAXY G3 MINI 1.00MM X 3.00CM (GLM910030) AND A GALAXY G3 MINI 1.00MM X 2.00CM (GLM9100

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000605 ↗
• MalfunctionDec 1, 2022Device Difficult to Setup or Prepare; Product Quality Problem; Difficult to Advance; Migration; Difficult or Delayed Separation; Device Difficult to Setup or Prepare; Product Quality Problem; Difficult to Advance; Migration; Difficult or Delayed Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE LEFT INTERNAL CAROTID ARTERY (ICA), C5 SEGMENT, A LVIS STENT WAS PARTIALLY RELEASED AND A GALAXY G3 MINI 1MM X 4CM COIL (GLM910040, 30757502) WAS PUSHED INTO AN ECHELON MICROCATHETER (MC). THE PHYSICIAN FELT SOME RESISTANCE AND ADDED MORE FORCE TO DELIVER THE COIL TO PASS THROUGH MICROCATHETER TIP, THE COIL SUDDENLY ARRIVED AT ANEURYSM WITHOUT INTENTION. THE PHYSICIAN TRIED TO RETRACTED THE COIL, BUT FAILED, THEN CONTINUED TO FILL THE ANEURYSM WITH COIL. THE COIL WAS SUCCESSFULLY RELEASED AFTER 3 ATTEMPTS AND THE REASON WAS UNKNOWN. THE PROXIMAL PART OF COIL WAS NOT COMPLETELY DETACHED IN ANEURYSM AND THE PHYSICIAN FIXED IT BETWEEN THE STENT AND THE VESSEL WALL WITH THE LVIS STENT. THE LOOP SIZE OF COIL IN ANEURYSM WAS 0.96X1.57MM WHICH IS GREATER IN LOOP THAN IDEAL LOOP SIZE OF 1MM. PER RESPOND OF DOCTOR, THE COIL WAS NOT ABLE TO BE ROTATED RANDOMLY AFTER REPEATED ADJUSTMENT DURING THE PROCEDURE, AND THE VIDEO SHOWED THAT THE COIL CAME OUT IN THE SAME DIRECTION ALL THE TIME. FINALLY, THE SHAPE OF COIL WAS NOT IDEAL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO OTHER DEVICES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893710 ↗
• MalfunctionNov 7, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING AN ARTERIOVENOUS FISTULA (D-AVM) IN THE CAVERNOUS SINUS, THE PACKAGE CONTAINING THE COMPLAINT COIL, A 1MM X 4CM GALAXY G3 MINI (GLM910040 / 30429000) WAS OPENED AS USUAL AND ENERGIZATION CHECK WAS PERFORMED. HOWEVER, ENERGIZATION COULD NOT BE CONFIRMED. THE COMPLAINT COIL WAS REMOVED AND REPLACED WITH ANOTHER COIL FROM A DIFFERENT LOT NUMBER. A CONTINUOUS FLUSH WAS MAINTAINED. THE CONCOMITANT MICROCATHETER USED WAS A PHENOM¿ MICROCATHETER (MEDTRONIC). THERE WAS NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748771 ↗
• MalfunctionNov 1, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR BLEEDING TO AN UNKNOWN TARGET VESSEL, A GALAXY G3 MINI 1MM X 4CM COIL (GLM910040, 30628970) WAS USED FOR HEMOSTASIS. A MICROCATHETER (MARVEL) WAS DELIVERED AND THE COMPLAINT COIL WAS USED. HOWEVER, THERE WAS RESISTANCE FELT INSIDE THE SHEATH WHILE BEING DELIVERED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (DIFFERENT LOT NUMBER) AND THE REPLACEMENT COIL WAS IMPLANTED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS MAINTAINED ON THE MICROCATHETER (MC). ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER (MC). NO DAMAGES WERE REPORTED ON THE COMPLAINT COIL. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS SEVERELY STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709768 ↗
• MalfunctionOct 31, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM ON THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) FOR ARTERIOVENOUS MALFORMATION (AVM), THE COMPLAINT COIL, A 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 30481275) WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). A CONCOMITANT MICROCATHETER, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS USED FOR THE SUPERIOR CEREBELLAR ARTERY (SCA) PERIPHERY AT 45 DEGREES ANGULATION. THE COMPLAINT COIL WAS DELIVERED TO A BLOOD VESSEL WHOSE DIAMETER WAS APPROXIMATELY 1MM. THE COMPLAINT COIL WAS WINDED WITHOUT PROBLEMS. DURING THE ATTEMPT TO DETACH BY PRESSING THE DEPLOYMENT BUTTON, HOWEVER, THE COMPLAINT COIL WAS UNABLE TO BE DETACHED EVEN THOUGH THE SOUND WAS HEARD. THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH, BUT THE SAME ISSUE WAS ENCOUNTERED. THE COMPLAINT COIL WAS REPLACED WITH A 1MM X 3CM GALAXY G3 MINI COIL AND THE REPLACEMENT COIL DETACHED. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT MAINTAINED. OTHER CONCOMITANT DEVICES USED WERE A CHIKAI 14 NEUROVASCULAR GUIDEWIRE (ASAHI INTECC) AND A 5FR FUBUKI GUIDING SHEATH (ASAHI INTECC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705130 ↗
• MalfunctionOct 1, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / K10166) WAS THE THIRD COIL USED. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526045 ↗
• MalfunctionAug 30, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FILED, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN UNKNOWN LOCATION, THE DELIVERY WIRE OF THE GALAXY G3 MINI 1MM X 4CM (GLM910040/ K10748) COULD NOT BE PUT INSIDE THE INTRODUCER. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT IT WAS NOT NECESSARY TO REPLACE OR REMOVE THE MICROCATHETER (UNKNOWN PRODUCT). THE SHAFT APPEARED TO BE KINKED, THE TIMING OF WHEN THIS CONDITION WAS NOTED, OR THE EXACT LOCATION OF THE KINK WERE NOT INDICATED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING THE DEVICE ADVANCEMENT. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL COMPONENT WAS FOUND TO BE DAMAGED. STRETCHED AND KINKED SECTIONS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319817 ↗
• MalfunctionJul 27, 2022Crack; Difficult to Advance; Crack; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A CEREBRAL COIL EMBOLIZATION FOR SAC GROWTH AND AFTER AFTER STENT PLACEMENT, A 1MM X 4CM GALAXY G3 COIL (GLM910040, 30649232) WAS USED. BEFORE INSERTING THE COMPLAINT PRODUCT INTO THE EXSELSIOR SL10 MICROCATHETER (MC), A CRACK WAS CONFIRMED WITH THE INTRODUCER SHEATH. WHEN THE DELIVERY WIRE WAS ADVANCED, THERE WAS A STRONG RESISTANCE FELT, THEREFORE, ANOTHER PRODUCT WAS USED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS AT THE BASILAR ARTERY (BA). ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NO ADDITIONAL INTERVENTION WAS REQUIRED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS SEVERELY KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114333 ↗
• MalfunctionApr 11, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / L15855) WAS THE THIRD COIL USED; IT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COMPLAINT COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT WAS OBSERVED THAT THE COIL WAS STRETCHED. THE PHYSICIAN USED ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079309 ↗
• MalfunctionMar 23, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), TWO 1MM X 4CM GALAXY G3 COILS (GLM910040, L15423) WOULD NOT ADVANCE INTO A STYKER SL-10 45 TIP 0165 MICROCATHETER (MC). THE FOLLOWING COILS WERE USED SUCCESSFULLY WITH THE SAME MC PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE: SPECTRA G3 AND GALAXY G3 MINI (2.5X5,2X6,2X4,2X4, 1.5X4,1.5X4,1.5X3). IT WAS NOT NECESSARY TO REMOVE THE MC. THERE WAS NO DAMAGE TO THE COMPLAINT COILS. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE GALAXY G3 MINI DEVICES RECEIVED, THE EMBOLIC COIL WAS KINKED ON ONE DEVICE AND THE EMBOLIC COIL WAS STRETCHED ON THE OTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870327 ↗
• MalfunctionMar 23, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), TWO 1MM X 4CM GALAXY G3 COILS (GLM910040, L15423) WOULD NOT ADVANCE INTO A STYKER SL-10 45 TIP 0165 MICROCATHETER (MC). THE FOLLOWING COILS WERE USED SUCCESSFULLY WITH THE SAME MC PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE: SPECTRA G3 AND GALAXY G3 MINI (2.5X5,2X6,2X4,2X4, 1.5X4,1.5X4,1.5X3). IT WAS NOT NECESSARY TO REMOVE THE MC. THERE WAS NO DAMAGE TO THE COMPLAINT COILS. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE GALAXY G3 MINI DEVICES RECEIVED, THE EMBOLIC COIL WAS KINKED ON ONE DEVICE AND THE EMBOLIC COIL WAS STRETCHED ON THE OTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870304 ↗
• MalfunctionMar 23, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN EMERGENT HEMOSTASIS, A 1MM X 4CM GALAXY G3 COIL (GLM910040, 30537007) WAS BEING USED, HOWEVER, IT WAS REMOVED FROM THE PATIENT¿S BODY BECAUSE IT BECAME STUCK IN THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE DEVICE RECEIVED THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862181 ↗
• MalfunctionMar 10, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL COMPONENT OF THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10217) WAS IMPEDED AND COULD NOT BE ADVANCED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10217), THE EMBOLIC COIL COMPONENT WAS OBSERVED IN A KINKED CONDITION INSIDE THE INTRODUCER. BASED ON THE PRODUCT ANALYSIS ON 10-MAR-2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726976 ↗
• MalfunctionMar 9, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CEREBRAL COIL EMBOLIZATION PROCEDURE OF AN UNRUPTURED ANEURYSM ON THE LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC), AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A 6FR AXCELGUIDE¿ GUIDING SHEATH(MEDIKIT CO, LTD), AND AN APPROACH TO THE LEFT COMMON CAROTID ARTERY (CCA). FROM THERE, A DD6 INTERMEDIATE CATHETER (MEDIKIT CO, LTD) WAS RAISED UP TO THE PETROUS AND A CONCOMITANT PHENOM¿ 17 MICROCATHETER (MEDTRONIC) WAS DELIVERED TO THE TARGET LESION ON THE ICPC. EMBOLIZATION WAS INITIATED BY PLACING A SHORYU SR 4-10 BALLOON CATHETER (KANEKA MEDIX) ON THE NECK. AFTER THE IMPLANTATION OF SOME COMPETITOR COILS, THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / 30392730) WAS CHOSEN FOR ADDITIONAL EMBOLIZATION. THE PHYSICIAN TRIED TO INTRODUCE THE COMPLAINT DEVICE INTO THE MICROCATHETER, BUT IT WAS NOT ABLE TO BE ADVANCED FURTHER. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY WITHOUT HAVING TO REMOVE THE CONCOMITANT MICROCATHETER, AN ATTEMPT WAS MADE TO ¿EXTRUDE¿ THE COIL FROM THE INTRODUCER, HOWEVER, IT DID NOT COME OUT FROM THE TIP OF THE INTRODUCER. IT WAS REPORTED THAT THERE WAS CONTINUOUS FLUSH MAINTAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171862. One submission often covers many models, so check the product and lot details in each record.

• Z-2280-2019 · May 16, 2019 · Terminated
  GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).